As we enter the 2019 labeling landscape—with changing regulations and slashed submission timelines—producing labels with 100% accuracy is proving to be increasingly complex and load-bearing for clinical supply teams.
In the months to come, here are a few key topics that we are keeping an eye on.
Regulatory Changes: Annex VI and Expiry Labeling? Brexit?
Time is running out to make plans on how to tackle the stricter EU guidelines that are set forward in Annex VI—the inclusion of an expiry date on primary packaging. Some countries (Spain, for example) have already explicitly stated this is a mandatory requirement and will not accept labels solely on outer packaging or via a centralized electronic randomization system.
Brexit is rapidly approaching, but with the impact on the European pharma landscape still largely unknown, companies are preparing for the worst and working with regulators, industry veterans, and various vendors to adjust previous ways of business to align with the changes.
On-Demand Regulatory Approved & Translated Labels
Technologies hitting the market this year will be able to take the average time to create regulatory and translated labels from weeks to minutes. As country lists change and clinical operations teams implement last-minute changes, clinical supply teams will be able to move with agility.
Clinical Supply Approval Solutions
Clinical supply teams are leaning into the use of technology solutions to streamline workflows and obtain greater visibility into each stage of a project. Solutions that allow teams to configure a desired workflow and permission levels while integrating with phrase translations have driven down timelines by 60% or more. These solutions could also help circumvent some of the impact of Brexit by providing a central location for communication and status review for teams in the UK versus elsewhere in the EU.
With an average cost per patient per trial of $35,000, the need to recruit, and more importantly retain, patients is critical. In order to hit the required enrollment numbers, we’ve seen a trend in the industry of trials expanding into new markets—particularly those markets that have roughly established regulatory guidance or leniency.
With the need for speed and quality continuously on the rise, we’ve seen an increase in the adoption of technologies that allow for flexibility and agility in the drug delivery and labeling methods. One trend we’ve seen explored is direct-to-patient IMP deliveries to make trial participation easier for patients, which will hopefully result in greater patient enrollment. In addition to flexibility in delivery, clinical supply teams are able to be more agile with label content with the use of electronic labels.
As these topics continue to take shape, TransPerfect Life Sciences is following along closely, and will be preparing to help you improve clinical supply management around the world—no matter how many regulatory changes pop up in the year to come.
For information on how we can support regulatory reviews and workflows, don’t hesitate to reach out to email@example.com.